Providing Comprehensive Services for Combination Product (in vivo implant and a medical device for subcutaneous insertion)
Premier Research assisted a small biotechnology company in support of a new therapeutic entity for the treatment of prostate cancer involving an in vivo implant and a medical device for subcutaneous insertion. Premier Research’s expertise was called on to assist in many phases of development including consulting services, conduct of the pivotal study, medical writing, harmonization of legacy data, submission of the NDA, safety reporting and negotiations with the FDA. The NDA was filed after patients completed 12 months of observation; patients continued to be followed while the submission was under review and 30-day safety reports were completed for these patients. A crucial review point was maintaining the implant, and the likelihood of successful implantation using the specially designed device. Premier Research was able to construct an analysis and present probability values that clarified the risk for explantations given the reported frequency. By combining Premier Research’s expertise in medical devices and oncology as well as its excellence in clinical research, the Sponsor received full approval to market the drug and manufacture and distribute the device within nine months of the initial submission.